Methods for accessing a left ventricle

ABSTRACT

Two minimally invasive therapeutic procedures, particularly for patients with congestive heart failure, may be performed separately or together. One procedure involves providing a valved passageway through the patient&#39;s left ventricular wall at the apex of the patient&#39;s heart and advancing instruments through the valved passageway to connect the valve leaflets of the patient&#39;s heart valve, e.g. the mitral valve. The second procedure involves advancing a pacing lead and a pacing lead implanting device through a trocar in the patient&#39;s chest and implanting the pacing lead on an exposed epicardial region of the patient&#39;s heart wall. The pacing lead has a penetrating electrode which is secured within the heart wall. Improved devices for these procedures include a minimally invasive grasping device for heart leaflets, a leaflet connector with artificial cordae tendenae and a pacing lead implant instrument.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of application Ser. No. 13/247,304,filed on Sep. 28, 2011, which was a continuation of application Ser. No.12/006,967, filed Jan. 8, 2008, which was a continuation in part ofapplication Ser. No. 11,784,385, filed on Apr. 6, 2007, which was acontinuation in part of application Ser. No. 10/313,198, filed on Dec.6, 2002 (now U.S. Pat. No. 7,373,207), which was a continuation in partof application Ser. No. 10/295,390, filed on Nov. 15, 2002 (now U.S.Pat. No. 6,978,176) which claimed priority from provisional applicationSer. No. 60/340,062, filed Dec. 8, 2001; provisional application Ser.No. 60/365,918, filed Mar. 20, 2002; and provisional application Ser.No. 60/369,988, filed Apr. 4, 2002. All of these applications areincorporated herein by reference in their entirety. The specification ofthe present application is identical to that of application Ser. No.10/295,390, filed on Nov. 15, 2002 (now U.S. Pat. No. 6,978,176).

BACKGROUND OF THE INVENTION

This invention is directed to therapeutic procedures for a patient'sheart and to instruments and systems for such procedures. The proceduresand the instruments and systems for such procedures are particularlysuitable for treating that patient suffering from the symptoms ofcongestive heart failure (CHF), and particularly to those CHF patientsexhibiting mitral valve regurgitation (MVR) and/or those exhibitingintraventricular conduction delay with resulting disturbance of thesynchronous right and/or left ventricular contractility.

There are over five million patients in the United States suffering fromcongestive heart failure and there are more than seven hundred thousandnew cases each year. For many of these patients medical therapy is notvery successful. Recent trials have shown that a significant number ofCHF patient's benefit from percutaneous ventricular pacing where pacingleads are introduced percutaneously and advanced within the patient'svasculature until the leads are disposed within the patient's coronarysinus. However, ventricular pacing has not been found successful for asignificant number of CHF patients for a variety of reasons. Forexample, in a number of procedures the coronary sinus cannot becannulate and even if cannulated, the leads can become displaced.

With many CHF patients, their ventricular ejection fraction is reduceddue to mitral valve regurgitation (MR) resulting from dilatedcardiomyopathy, which is the deformity of the heart which accompaniesCHF. The MR in turn can exacerbate the cardiomyopathy leading to aworsening of the MR. The MR can also be the result of torn cordaetendenae which can also prevent complete closure of the valve.

Surgical procedures for mitral valve repair for MR typically involvesvalve support ring at the base of valve. Recent advances in valve repairinclude securing together the free edges of the mitral valve leaflets bysutures staples and the like, commonly called “Bow-Tie” or “edge toedge” techniques. These procedures usually involve open heart surgeryincluding cardiopulmonary bypass and a sternotomy, although morerecently some of these procedures have been performed by minimallyinvasive and percutaneous techniques which can reduce the morbidity ofsuch procedures. Percutaneous procedures impose difficulties ininstrument design because the instruments for such procedures must belong enough, have small enough profile and have sufficient flexibilityfor advancement through the patient's vasculature into the patient'sheart chamber. However, they must also be able to accurately locate theoperative ends of such instruments at a desired location within thechambers of the patient's beating heart and be strong enough to performthe required functions.

Techniques for Bow-Tie repair of mitral valves have been mentioned inthe patent literature, but specific instruments for such techniques arenot yet commercially available.

BRIEF SUMMARY OF THE INVENTION

This invention generally relates to minimally invasive therapeuticprocedures, including valve repair and ventricular pacing, for patientswith CHF and to the devices and systems suitable for use in suchprocedures. Specifically, one aspect of the invention is directed togaining access to a patient's heart chamber through the wall of thepatient's heart, such as at the apex thereof, for repairing damaged orotherwise incompetent heart valves. The invention is also directed tothe attachment of a pacing lead to an exterior region of the patient'sheart wall for ventricular pacing. These procedures provided alone andparticularly when performed together provide significant relief andlonger life to symptomatic CHF patients. Moreover, due to the minimallyinvasive nature of these procedures, many of the CHF patient population,who are otherwise unsuitable for conventional treatments, may be treatedwith the present procedures.

While the procedure is primarily described herein for repairing damagedor otherwise incompetent valves between chambers of the patient's heart,the procedure can be employed in a variety of treatments or diagnoseswithin the patient's heart chambers. Other procedures which may beperformed include transmyocardial revascularization, aortic stenting foraortic dissections and aneurysm therapy, removal or clots andvegetations of prosthetic valves, excision of heart tumors, stem celland vascular growth factor implantation, ventricular septal defectclosure and the like.

The procedure related to valve repair generally includes first gainingaccess to the patient's chest cavity through a small opening made in thepatient's chest to gain access the chest cavity, preferably though anintercostal space between two of the patient's ribs. Such accessing canbe effected thorocoscopically through an intercostal space between thepatient's ribs by minimally invasive procedures wherein a trocar orother suitable device is placed within the passageway in the patient'schest to the patient's chest cavity.

The patient's heart wall is pierced to provide a passageway through theheart wall to a heart cavity such as the left ventricle, defined in partby the pierced heart wall. Preferably, the passageway is formed througha region of the heart wall at or near the apex of the patient's heart.Suitable piercing elements include a 14 gauge needle. A guide wire isadvanced through the inner lumen of the needle into the heart chamberand further advanced through the valve to be treated into an adjacentheart chamber. The needle may then be removed leaving the guide wire inplace. A valve is advanced over the guide wire and installed in theventricular wall passageway which is configured to enable passage ofinstruments for the procedure through the heart wall into the heartchamber while preventing loss of blood through the passageway. The valvemay be permanently or temporarily within the heart wall passageway. Adog-boned shape balloon can be utilized to seat the securing elements ofthe valve within the passageway.

The instruments for performing the procedure may then be passed throughthe valve seated in the passageway. The proximal ends of theseinstruments extend out of the patient to allow the instruments to bemanipulated to more accurately position the operative ends of theinstruments at the desired location within the heart chamber to performthe procedure and to operate the operative member which may be providedon the distal ends of these instruments.

An expandable stabilizing instrument is provided to stabilize the tissuestructure within the heart chamber at a grasping location, such as themitral valve leaflets upon which the procedure is to be performed. Inthe case of mitral or atrioventrical valve repair, the stabilizinginstrument is a catheter having one or more expandable members on adistal location thereof, such as an inflatable balloon or expandablearms, which can engage the atrial surface of the valve leaflets tostabilize and urge the valve leaflets toward a grasping location in theleft ventricle to allow the grasping member to engage and hold the valveleaflets together so that the free ends of the leaflets can be securedtogether by suitable connecting elements. Suitable leaflet connectingelements include clips, staples, and the like. The distal extremity ofthe catheter having the expandable member is advanced into the atrialchamber. The expandable member(s) e.g. an inflatable balloon or one ormore arms or struts are expanded and then the catheter is pulledproximally to engage the expandable member(s) against the atrial side ofthe valve leaflets and push the leaflets into the grasping locationwithin the ventricular chamber.

An elongated grasping device with at least a pair of grasping memberssuch as jaws on the distal end thereof for grasping tissue structure isadvanced through the valve until the distal end extends out of thedistal end of the guiding catheter. The grasping members or jaws of thegrasping device are operated from the proximal end of the graspingdevice which extends out the proximal end of the guiding catheterextending out of the patient. The jaws of the grasping device are openedto engage the stabilized valve leaflets in the grasping location andthen closed to grip the leaflets so that the free edges of the valveleaflets are placed into an operative position for the Bow-Tie repair.The free ends of the grasped valve leaflets may be joined or otherwisesecured together by suitable connecting elements such as clips, staplesand the like. Once the free edges of the valve leaflets are securedtogether, the instruments for the procedure may be withdrawn through thevalve in the heart wall and then the opening in the patient's chest. Thevalve will close upon instrument removal to eliminate or at leastminimize blood leakage through the valve. The valve may be left in placeor removed and the passageway sutured closed.

When there is cordae tendenae damage with the heart valve, particularlywhen there is severance of the cordae tendenae from the valve leaflet orthe papillary muscle, repair of the valve leaflet, even by means of theBow-Tie technique, may not prevent reshaping of the ventriculararchitecture which can reduce ventricular output. In that instance, ithas been found that providing an artificial cordae tendenae such as astrand extending between the valve leaflets and the heart wall ingenerally the same orientation as the cordae tendenae will support theconnected valve leaflets in more or less a normal manner to minimizeventricular deformation (e.g. dilation) which leads to decreased output.One end of the strand is secured to the connecting element securing thefree edges of the valve leaflets or to the free edges themselves and theother end of the strand is secured to a location on the heart wall,preferably on the exterior of the heart wall. The strand should berelatively inelastic or non-compliant to ensure an effective closedposition of the leaflets. In this case it is preferred that thepassageway through the ventricular wall pass through the apex region ofthe heart between the two papillary muscles in the left ventricle, sothat the pull on the valve leaflets by the strand secured to theleaflets is in approximately the same angle or orientation as thenatural pull by the competent cordae tendenae. This provides for abetter seal of the leaflets and thereby minimizes leakage through thevalve.

Other procedures which may also be performed through the seated valve inthe heart wall passageway in addition to valve repair includetransmyocardial revascularization where a tissue ablation instrument isadvanced into the heart chamber for ablating tissue in an ischemicregion of the ventricular wall. It is generally thought that the tissueablation in the ischemic region causes angiogenesis and thusrevascularization which returns blood flow to the region. For TMRprocedures in some regions of the heart chamber, a secondary orsubselective guiding catheter having a preshaped distal tip may beneeded to orient the ablating tip to the desired ischemic region of thepatient's heart wall. A similar procedure may be utilized to ablateregions of the intraventricular wall to terminate or curtail arrhythmia.Other procedures are contemplated.

The minimally invasive placement of a pacing lead having a penetratingelectrode is performed through a small opening in the patient's chest inthe intercostal space between ribs. The small opening is preferablyprovided with a suitable trocar such as those available commercially.The distal end of the pacing lead is introduced into the patient's chestcavity through the trocar and the penetrating electrode on the distalend of the pacing lead is inserted into an exposed epicardial surface onthe patient' ventricular wall which defines the heart chamber such asthe left ventricle. The pericardium is removed from the region to exposethe epicardium. The proximal end of the pacing lead is configured to beconnected to an electrical power source such as those used for pacingpurposes which produce a pulsed electrical output of suitable frequency,current and voltage levels to control the contraction of the ventricularwall to which the pacing lead is attached. The pacing lead may betunneled subcutaneously to the power source. The penetrating electrodepreferably has hooks or other suitable structures for preventing removalof the electrode from the heart wall. The penetrating electrode may takethe form of an arrow, fish-hook or helical coil. Other shapes aresuitable.

The devices suitable for installing the pacing lead in the exterior ofthe heart wall are configured to be advanced through the trocar or smallopening in the patient's chest and press or otherwise put thepenetrating electrode of the pacing lead within the ventricular wall.

The output from the paced heart chamber is greatly increased and inconjunction with a repaired valve preventing or minimizingregurgitation, the CHF patient has a significant improvement in physicalwell being, life extension and quality of life.

These and other advantages of the invention will become more apparentfrom the following detailed description and accompanying exemplarydrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention has other advantages and features which will be morereadily apparent from the following detailed description of theinvention and the appended claims, when taken in conjunction with theaccompanying drawings, in which:

FIG. 1 is a perspective view of a patient's chest, partiallyillustrating the location of the patient's heart within the chestcavity, with part of the heart wall removed to expose the leftventricular chamber and illustrate torn cordae tendenae connected to oneof the valve leaflets.

FIG. 2A is a transverse cross-sectional view taken along the lines 2-2shown in FIG. 1 illustrating the incompetent mitral valve in a closedcondition during systole.

FIG. 2B is a transverse cross-sectional view taken along the lines 3-3shown in FIG. 2 illustrating the incompetent valve in an open conditionduring diastole.

FIGS. 3A and 3B are transverse cross-sectional views similar to thoseshown in FIGS. 2A and 2B but of a competent mitral valve.

FIGS. 4A and 4B are transverse cross-sectional views similar to thoseshown in FIGS. 2A and 2B wherein the valve leaflets are secured togetherin a “Bow-Tie” configuration.

FIG. 5 is a partial elevational view in section of a patient's leftventricle illustrating a valve seated in the apical ventricular wall.

FIG. 6 is an enlarged perspective view of the valve shown in FIG. 5.

FIG. 7 is a longitudinal cross-sectional view taken along the lines 7-7shown in FIG. 6.

FIG. 8 is a top view of the valve taken along the lines 8-8 shown inFIG. 6.

FIG. 9 is a partial elevational view, in section of the left side of thepatient's heart illustrating the positioning of a guide wire in thepatient's heart interior with the shaped distal tip of a guide wire inthe patient's left atrium.

FIG. 10 is a partial elevational view, in section of the left side ofthe patient's heart illustrating the advancement of a grasping deviceover the guide wire shown in FIG. 9.

FIG. 11 is a partial elevational view, in section of the left side ofthe patient's heart illustrating the positioning of the grasping memberson the distal end of the grasping device shown in FIG. 10 over the guidewire into the patient's left atrium.

FIG. 12 is a partial elevational view, in section of the left side ofthe patient's heart illustrating the advancement of a balloon catheterinto an inner lumen of the grasping device for deployment within thepatient's left atrium.

FIG. 13 is a partial elevational view, in section of the left side of apatient's heart illustrating the inflation of the balloon on the distalend of the balloon catheter within the patient's left atrium.

FIG. 14 is a partial elevational view, in section of the left side of apatient's heart illustrating the positioning of the valve leaflets in agrasping location by the balloon catheter with the expanded graspingmembers of the grasping device being disposed within the left ventriclein a position to grasp the valve leaflets.

FIG. 15 is a partial elevational view, in section of the left side of apatient's heart illustrating the grasping of the valve leaflets by thegrasping members of the grasping device.

FIG. 16 is a partial elevational view, in section of the left side of apatient's heart illustrating the connecting the free edges of the valveleaflets with a clip in a Bow-Tie arrangement.

FIG. 17 is an enlarged view of the distal end of the grasping device asshown in FIG. 16 with a clip is position partially pressed into aconnecting relationship with the free edges of the valve leaflets.

FIG. 18 is a transverse cross-sectional view taken along the lines 18-18shown in FIG. 17 illustrating the clip partially connected to the valveleaflets.

FIG. 19 is an elevational view of a grasping device embodying featuresof the invention.

FIG. 20 is a transverse cross-sectional view of the grasping deviceshown in FIG. 19 taken along the lines 20-20.

FIG. 21 is an enlarged longitudinal cross-sectional view of the distalend of the grasping device with a valve leaflet connecting memberslidably disposed within the inner lumen of the grasping device.

FIGS. 22-24 are transverse cross-sectional view taken along the lines22-22, 23-23 and 24-24 of the grasping device shown in FIG. 21.

FIG. 25 is a transverse cross-sectional view taken along the lines 25-25illustrating the pusher bar pushing the clip along the guide way lumenof the grasping device shown in FIG. 19.

FIG. 26 is an enlarged elevational view of the clip with a artificialcordae tendenae strand secured to the closed end of the clip.

FIG. 27 is a partial elevational view, in section of the left side of apatient's heart illustrating the artificial cordae tendenae extendingfrom the clip to the exterior of the patient's heart.

FIG. 28 is a perspective view of a patient's chest, partiallyillustrating the location of the patient's heart within the chestcavity, with part of the heart wall removed to expose the leftventricular chamber and illustrating placing the penetrating electrodeof a pacing lead within the heart wall defining in part the leftventricle.

FIGS. 29-31 illustrate a suitable minimally invasive device forimplating a pacing lead in a patient's heart wall.

FIGS. 32 and 33 illustrate an alternative embodiment of a minimallyinvasive device for implating a pacing lead in a patient's heart wall.

FIG. 34 illustrates another minimally invasive device for implating apacing lead in a patient's heart wall.

The drawings are for the most part schematic presentations and not toscale.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 illustrates a patient's heart 10 with the left side of the heartin partial cross-section schematically showing the patient's left atrium11 and left ventricle 12 with a mitral valve 13 disposed between theleft atrium and the left ventricle having a posterior valve leaflet 14and an anterior leaflet 15. Each of the valve leaflets 14 and 15 havecordae tendenae 16 and 17 respectively which are connected to theleaflets and to papillary muscles 18 and 19 respectively within the leftventricle at the apex 20 of the heart. The posterior leaflet 14 of themitral valve 13 is shown with its cordae tendenae 16 partially torn. Thefree edge 21 of the posterior leaflet is uncontrolled due to the torncordae tendenae which makes the valve incompetent to close completelywhen the heart contracts during systole. This result in regurgitation ofblood back through the valve which in turn results in lowered bloodoutput for the left ventricle. The anterior valve leaflet 16 is shownwith its cordae tendenae 17 completely attached.

FIGS. 2A and 2B illustrate the closed and open condition respectively ofan incompetent mitral valve 13 such as that shown in FIG. 1. The freeedge 21 of posterior valve leaflet 14 is unable to close completelyagainst the free edge 22 of anterior leaflet 15 due to the torn cordaetendenae as depicted in FIG. 1. A similar leaflet condition may occurdue to dilated ventricular architecture, i.e. dilated cardiomyopathy,characteristic of congestive heart failure.

FIG. 3A illustrates a healthy competent mitral valve 13 with valveleaflets 14 and 15 which is closed completely during systole to preventregurgitation of blood through the valve. FIG. 3B illustrates thecompetent mitral valve shown in FIG. 2A in an opened condition duringdiastole to allow blood to flow from the left atrium to the leftventricle.

FIGS. 4A and 4B illustrate the closed and opened conditions of a mitralvalve 13 in which the free edge 21 of posterior valve leaflet 14 and thefree edge 22 of the anterior leaflet valve 15 are secured together in aBow-Tie connection by a suitable clip 49, such as is shown in FIG. 26.During systole when the heart contracts, the clip holds the free edges21 and 22 of the valve leaflets together to minimize blood regurgitationthrough the valve. However, during diastole, when the heart musclerelaxes and the blood pressure within the left ventricle is reduced, themitral valve 13 opens up much like a competent valve but with twoopenings 23 and 24 between the valve leaflets 14 and 15. Theinterference with blood flow through the two openings 23 and 24 of arepaired mitral valve with a Bow-Tie connection between the leaflets isminimal compared to the flow with a single opening for a competentmitral valve.

FIG. 5 illustrates a left side of a patient's heart such as is shown inFIG. 1 with an incompetent mitral valve 13 due to torn cordae tendenae14. A valve 30 embodying features of the invention is deployed within apassageway 31 through the free ventricular heart wall 32. As is shown inmore detail in FIGS. 6-8, the valve 30 has a cylindrical structure 33which is secured within the passageway 31 by elements 34 which may bebarbs or hooks. The valve component 35 of valve 30 is a duck billedvalve component formed of polymeric material which allow the passage ofinstruments for deployment or treatment but prevent or at least minimizeloss of blood through the heart wall. The cylindrical structure 33 maybe in a form similar to a stent and is preferably expandable tofacilitate its deployment. However, the cylindrical structure 33 mayhave any suitable structure or be formed of any suitable material whichsupports the valve component 35. The elements may be forced into thesurrounding tissue of the heart wall by means of a dumbbell shapedinflatable balloon.

FIGS. 9-18 depict a grasping device 40 which embodies features of theinvention and the use of the device to secure the valve leaflets in aBow-Tie connection. The grasping device 40 has an elongated shaft 41, aplurality of grasping members or jaws 42 on the distal portion of theshaft and finger operated handles 43 and 44 which operate the jaws 42through pull wires 45 and 46. The grasping members or jaws 42 arepivotally mounted at the pivot point 47 on the distal end of shaft 41.While only two jaws 42 are shown, three or more jaws may be employed.The elongated shaft 41 of grasping device 40 has an inner lumen 48extending therein to allow for the passage of instruments that aid oreffect the deployment of a connecting member to the free edges of thevalve leaflets to perform a Bow-Tie connection thereof as will bedescribed in more detail hereinafter. FIG. 21 is an enlarged elevationalview in section to illustrate the leaflet clip 49 and the pusher bar 50which pushes the clip through the inner lumen 48. As shown in moredetail in FIGS. 22-25, tapered grooves 65 and 66 are provided in thejaws 42 so that, as the clip 49 is pushed toward the distal ends of thejaws 42, the clip slides along the tapering grooves and is closedagainst free edges 21 and 22 of the leaflets 14 and 15 grasped by thejaws. The deployed leaflet clip 49 closed against the free leaflet edges21 and 22 in a Bow-Tie connection is shown in FIGS. 17 and 18. The innerlumen 48 continues through the jaws 42 to a port 51 to allow passage ofother instruments such as the distal portion of the balloon catheter 52which positions the leaflets 14 and 15 in the grasping location as shownin FIG. 14.

The use of the grasping device 40 is illustrated in FIGS. 10-18. Afterthe one-way valve 30 is properly secured within the passageway 31through the ventricular wall 32, a guide wire 53 is advanced through thevalve 30 into the left ventricle 12 and further advanced through themitral valve 13 into the left atrium 11 as shown in FIG. 10. A graspingdevice 40 is mounted on the proximal end of the guide wire 53 whichextends out of the patient and is slidably advanced over the guide wirethrough the valve 30, and into the left atrium through the mitral valve13. The guide wire 53 at that point is slidably disposed within theinner lumen 48 of the grasping device 40. A balloon catheter 52 may thenbe advanced over the guidewire 53 through the inner lumen 48 of thegrasping device 40 until the inflatable balloon 54 on the distal portionof catheter 52 is disposed in the left atrium. The balloon 54 isinflated by injecting inflation fluid through an inner lumen (not shown)in the shaft of the balloon catheter 52 by means of the syringe 55 asshown in FIG. 14. If the shaft of the balloon catheter 53 is stiffenough, the guide wire 53 may be withdrawn prior to insertion of theballoon catheter 52 and the catheter advanced through the inner lumen 48of grasping device 40 by itself.

After the balloon 54 is inflated within the left atrium 11, the shaft ofthe balloon catheter 52 is pulled proximally to press the inflatedballoon 54 against the atrial side of the mitral valve leaflets 14 and15 to urge the leaflets into grasping location as shown in FIG. 14. Thejaws 42 may then be closed on the valve leaflets 14 and 15 as shown inFIG. 15. As previously described, the leaflet clip 49 may be advancedthrough the inner lumen 48 by pusher bar 50 to close the clip 49 againstand through the grasped free edges 21 and 22 as shown in FIGS. 17 and18. After the clip 49 has been deployed to form the Bow-Tie connection,the grasping device 40 and any other devices that may be present arewithdrawn from the patient's heart through the valve 30. The duck-billedvalve component 35 closes down after removal of the various instrumentsand prevents loss of blood from the left ventricle. If desired, thevalve 30 may be removed and the proximal opening of the ventricularpassageway sutured closed.

In an alternative embodiment is shown in FIG. 27 wherein an elongatedstrand 56 formed of relatively non-compliant material may have one end57 secured to the closed end of leaflet clip 49. After deployment of theclip 49 to connect the free edges 21 and 22 of the leaflets 14 and 15 ina Bow-Tie connection, the proximal end 58 of the strand 56 is pulledtaut to position the leaflets 14 and 15 in a natural position to ensureproper closure during systole and then the proximal end 58 of the strand56 is secured to the free ventricular wall 32, preferably to theexterior thereof, such as shown suturing with a pledget 59. Thisembodiment is particularly suitable in those instances wherein cordaetendenae connected to the valve leaflet are torn. The strand 56 thenacts as an artificial cordae tendenae to the leaflet. However, care mustbe exercised when securing the proximal end 58 of the strand 56 issecured to the heart wall 32 that the valve leaflets are in a naturalposition so as to prevent or reduce regurgitation through the valve 13.

The hearts of many CHF patients exhibit intraventricular conductiondelay with resulting disturbance of the synchronous right and/or leftventricular contractility. As previously mentioned, a large populationof the CHF patients are not suitable candidates for or fail percutaneousdelivery of pacing leads to provide relief from CHF. In these instances,it has been found that a pacing lead secured to the exterior walldefining in part the heart chamber exhibiting the conductance delay canbetter control the contraction of the heart to improve the chamber'sejection.

As shown in FIG. 28, the pacing lead 60 can be deployed within thepatient's chest cavity by minimally invasive techniques through a trocar61 located in the intercostal space between the patient's ribs. Theplacement of the pacing lead 60 can be observed by an endoscopic video62 extending through an intercostal space. Instruments to facilitate theimplantation of the helically shaped electrode 63 of the pacing lead 60can be passed through the trocar 61 and the electrode secured within theheart wall 32 by minimally invasive techniques. The pacing lead 60 hasits proximal end configured to be electrically connected to a pacingpower source 64 which is preferably disposed at a subcutaneous location.The pulsed output of the power source 64 may be controlled in aconventional manner to provide the desired contractions to the heartwall to which the pacing lead is secured.

FIGS. 29 to 31 illustrate a minimally invasive embodiment havingfeatures of the invention to secure an electrode of a pacing lead withinthe free wall defining the left ventricle of the patient's heart tocontrol the contraction of the left ventricle and improve the outputthereof. This device 70 includes a tubular delivery member 71 having aproximal end 72 with a port 73, an enlarged distal end 74 with a port 75and inner lumen 76 extending within the tubular member from the proximalport 73 to the distal port 75. The distal end of the tubular member 71is enlarged to receive a longitudinally expansive member such asinflatable balloon 77. The balloon 77 is provided with an elongatedshaft 78 having an inner inflation lumen (not shown) which allowsinflation fluid to be introduced into the interior of the balloon toinflate the balloon. The distal end of tubular member 71 is providedwith a vacuum pod 79 to secure the distal end to the exposed surface ofthe free ventricular wall 32. The interior of the pod 79 is connected tothe vacuum tube 80 which is in turn configured to be connected to avacuum source (not shown). The pacing lead 81 has a collar 82 securedabout a distal portion thereof which is configured to be engage by theballoon 77 when the latter is inflated to drive the penetratingelectrode 83 on the pacing lead against the exposed ventricular wall 32so that the penetrating electrode 83 penetrates into and is securedwithin the ventricular wall. The tubular member 71 may have a flexiblesection 84 to facilitate articulation of the distal extremity of thetubular member 71 to aid in the placement of the vacuum pod 79 to theexterior of the heart wall 32. The vacuum pod 79 is configured to passthrough a trocar provided in an intercostal space between the patient'sribs.

The pacing lead 81 shown in FIGS. 29-31 is installed by first making asmall opening in the patient's chest and implacing a first trocar (notshown) having an inner lumen. Commercially available trocars includetrocars from U.S Surgical and others. A second similar trocar (notshown) is installed in a similar manner for a thorocoscope such as shownin FIG. 28, which allows the operating surgeon to view the region inwhich the pacing lead is to be installed and to place a variety ofinstruments within the patient's chest cavity. Other trocars may also beinstalled for other purposes.

The lower left lobe of the patient's lung is moved out of the way toexpose the patient's heart. The pericardium on the free wall 32 definingin part the patient's left ventricle is removed from the desiredepicardial site in which the pacer lead is to be secured. The pacer leaddelivery tube 71 is introduced into the patient's chest cavity throughthe first trocar and advanced within the chest cavity toward the exposedepicardial surface. The open end of the vacuum pod 79 on the expandeddistal end of the delivery tube is pressed against the exposedepicardial surface and a vacuum is developed within the inner chamber ofthe pod to hold the distal end of the tubular member 71 against theepicardial surface. Inflation fluid is introduced into the interior ofthe balloon 77 through the inflation lumen in tube 78. The expandeddistal end 74 of the delivery tube 71 limits the radial expansion of theballoon, so the balloon expands longitudinally in the distal directionas shown in FIG. 31. The longitudinal expansion causes the distal end ofthe balloon to expand against the flange secured to the distal portionof the pacer lead. Balloon pressure on the collar 82 drives the pacinglead toward the epicardial location on the exterior of the patient'sheart and the penetration electrode 83 on the distal end of the pacinglead into the ventricular wall. The barbs 85 on the penetrationelectrode secure the electrode within the heart wall and prevent theelectrode from being pulled out of the wall. Electrical pulses from asuitable electrical power source are applied to the proximal end of thepacer lead. The electrical pulses are transmitted through the pacinglead conductor to the electrode secured within the heart wall. Thepulses are emitted from the secured electrode into the tissue of theheart wall to pace the patient's left ventricle. The pacing iscontrolled in order to increase the volume of blood pumped out of theheart chamber.

An alternative device 90 is shown in FIGS. 32 and 33 which has anelongated tubular shaft 91 with a proximal end 92, a distal end 93, asemispherical shaped housing 94 on the distal end with an annular vacuumchamber 95 around the lower edge of the semi-spherical housing. An innerlumen 96 extends through the tubular shaft 91 which is in fluidcommunication with the vacuum chamber 95 in the housing. The proximalend 92 of the tubular member 91 is configured to be connected in fluidcommunication with a vacuum source (not shown). A second tubular member97 extends through the tubular member 91 and is connected in fluidcommunication with the interior of balloon 98 located within thesemi-spherical housing in order to direct inflation fluid thereto. Apacing lead 99 extends along, but exterior to, the tubular member 91 andhas a distal end with a balloon support platform 100 and a tissuepenetrating electrode 101 extending away from the platform. The distalportion of the tubular shaft is provided with some degree of flexibilityin order to ensure that the spherical housing is in a proper orientationto be pressed against the exposed epicardial surface for sealing thevacuum chamber against the surface. With the vacuum chamber securedagainst the epicardial surface 32, the balloon 98 is inflated to drivethe supporting platform 100 and the connected penetrating electrode 101toward the epicardial surface. The electrode 101 is driven into the wallof the patient's left ventricle and the barbs 104 thereon secure theelectrode within the wall tissue to prevent its removal. Electricalpulses from a suitable power source may then be applied to the tissuewithin the heart wall to pace the contraction thereof as discussed aboveto increase the output of blood from the heart chamber. The balloon 98is releasably secured to the support platform 100 so that when theelectrode is driven into the heart wall, the balloon can be deflated andthe vacuum within the vacuum chamber of the semi-spherical housing maybe released and the assembly withdrawn from the patient through thetrocar through which it was delivered. The proximal end of the pacinglead may then be directed to the power source and connected thereto.

Another alternative embodiment is shown in FIG. 34, which has anelongated tube 110 with a grasping mechanism therein and a pair ofgrasping tongs 111 on the distal end of the mechanism configured to besecured to a pacing lead. The embodiment has a housing 112 on theproximal end with a rotating lead holder which when rotated rotates thepair of tongs 111 on the distal end of the mechanism. A button 113 isprovided to disengage the tongs from the pacing lead 114. The rotationof the tongs 111 causes the rotation of the pacing lead and the helicalelectrode 115 to screw into the heart wall. This device will soon beoffered by Medtronic as an epicardial lead implant tool (Model No.10626) which is designed to be used with a Model 5071 pacing lead.

Usually an additional (conventional) pacing lead is installed in thepatient's right ventricle for complete resynchronization of the heartchambers. The additional lead is preferably connected to the same powersource as the first described pacing lead which may be located in theinfraclavicular pocket in a conventional manner.

EXAMPLE

Twenty patients were selected (12 men, 8 women) for thorocoscopicallydirect left ventricular lead placement. The patients had New York HeartAssociation Class III or IV congestive heart failure with a meanejection fraction of 20%.+−0.8%. All of the patients had previouslyundergone transvenous right-ventricular lead placement and subcutaneousimplantation of a dual or triple chamber pacement but had failedtransvenous left-ventricular lead placement due to suboptimal coronaryvein anatomy. Surgical entry into the left chest was carried out througha 2 cm incision in the mid acillary line at the sixth intercostal space,following collapse of the left lung. A 15 mm thoracoport (U.S. Surgical)was inserted with the tip of the trocar pointing to the left should tominimize contact with the heart. A 5 mm rigid port was insertedinferolateral to the left nipple of the patient in the sixth intercostalspace to allow insertion of a grasper such as the U.S. SurgicalEndograsper. Another 5 mm rigid port is inserted in the fourthintercostal space at the anterior axillary line for a scope and camera.A portion of the pericardium was removed to provide an exposedepicardial region for implantation of the helical electrode of thepacing lead. Screw in epicardiac leads (Medtronic 5071 and Guidant 4047)were inserted under video control through the 15 mm trocar or rigidport. The leads were inserted into the epicardium by applying gentlepressure and three clock-wise full rotations of the pacing lead holder.If pacing voltage thresholds were unacceptably high the pacing leadwould be twisted one-quarter turn and then retested. Acceptable pacinglead placement is defined as 100% pacing at 2.5 volts or less. The videoassisted left-ventricular lead placement was successful in nineteen ofthe twenty patients. The one failure required an open thoracotomy.

While the above is a complete description of the preferred embodimentsof the invention, various alternatives, modifications, and equivalentsmay be used. Therefore, the above description should not be taken aslimiting the scope of the invention which is defined by the appendedclaims.

What is claimed is:
 1. A method for accessing a left ventricle of aheart, said method comprising: placing a valve structure through apassageway in an apical wall of the heart; forcing a securing elementinto tissue surrounding the valve structure to secure the valvestructure in the passageway; and introducing a tool through the valvestructure into the left ventricle.
 2. A method as in claim 1, whereinthe valve structure has an exit at an inner surface of the leftventricle.
 3. A method as in claim 2, wherein the valve structure has anentrance at an outer surface of the heart.
 4. A method as in claim 1,wherein the securing element is attached to an outer surface of thevalve structure.
 5. A method as in claim 4, wherein the securing elementis disposed circumferentially about a cylindrical wall of the valvestructure.
 6. A method as in claim 5, wherein the securing elementcomprises a plurality of hooks or barbs.
 7. A method as in claim 1,wherein the valve structure comprises a one-way valve.
 8. A method as inclaim 7, wherein the one-way valve comprises a duck bill valve.
 9. Amethod as in claim 1, wherein introducing a tool comprises engaging aheart valve.
 10. A method as in claim 9, wherein engaging a heart valvecomprises repairing an incompetent heart valve.
 11. A method as in claim10, wherein the incompetent heart valve comprises a mitral valve.
 12. Amethod as in claim 1, wherein introducing a tool comprises a procedureselected from the group consisting of transmyocardial revascularization,aortic stenting for aortic dissections and aneurysm therapy, removal ofclots and vegetations from prosthetic valves, excision of heart tumors,implantation of stem cell and vascular growth factors, and closure ofventricular septal defects.